Archive for the ‘Clinical Trials’ Category
ClinicalTrials.gov has launched a new beta version of its website, featuring a new integrated homepage and updated graphic design. In addition to the redesign, visitors will also have access to new and reorganized written content about clinical research, background information about the site, searching for studies, and maintaining study records. However, core functions of the site; including the basic and advanced search, search results options, and the study record data, will remain the same. The new site interface will run in parallel with the previous version for approximately four weeks after launch. After appropriate testing and additional minor changes it will permanently replace the previous interface in mid-September 2012.
ClinicalTrials.gov is the NLM-developed web-based registry and results database of clinical research studies. The website provides patients, clinicians, researchers, and the public with access to information about interventional and observational studies. As of August 2012, ClinicalTrials.gov contained over 130,000 clinical research studies in all fifty states and in 179 countries. Since it was launched in 2000, ClinicalTrials.gov has expanded in terms of scope, features, and intended audiences in response to the evolving policies and laws promoting the registration of clinical trials. For example, Congress enacted legislation in 2007 that added the first public results database. As a result, summary information about clinical trials of FDA-approved medical products would be freely available, whether or not the results were published in the medical literature. To accommodate the results database, new user interface features in ClinicalTrials.gov were launched in 2008, to display the results data tables and allow for searching of studies with results. Over time the Web site has featured the American Customer Satisfaction Index survey tool to collect feedback from users and usability evaluations have been conducted. The results of this user feedback, as well as the changing nature of the Web site, provided the motivation for redesigning ClinicalTrials.gov.
For additional information on the new site navigation features, new appearance, and new content, please visit the NLM Technical Bulletin and the ClinicalTrials.gov beta website.
MLA Continuing Education credit is now available for our monthly Midday at the Oasis sessions! You need to register ahead of time in order to receive the credit. The usual place to register is linked on the Training and Exhibit Calendar or on the Midday listing. One hour of MLA CE credit will be awarded for the Midday sessions.
The July 18th talk is:
Presentation Title: ClinicalTrials.gov: Results Reporting, Unique Evidence, and Evolving Policy
Presenter: Stephen Kiyoi
Description: ClinicalTrials.gov, the second most heavily visited resource from the National Library of Medicine, now provides access to over 6,000 study results, many of which have not been published in the research literature. Learn more about recent and upcoming legislation governing results reporting, how to promote results reporting to clinical researchers at your institution, and how to search ClinicalTrials.gov as a unique source of evidence for systematic reviews.
Register and join us at 1-2PM (Pacific) | 10-11AM (Hawaii) | 1-2PM (Arizona) | 9-10AM (American Samoa) | 6-7AM Thursday (Guam) for Midday at the Oasis!
The Annual Meeting of the Medical Library Association (MLA) was held May 18-23, 2012 at the Washington State Convention Center in Seattle, WA. Attendees were invited to visit the NLM exhibit booth to meet NLM staff and see NLM Web products and services. The NLM Theater at the booth featured demonstrations and tutorials on a wide variety of topics. Recordings of the NLM Theater Presentations are now available:
In addition, the PowerPoint presentations from the NLM Online Users’ Meeting, NLM Update, and DOCLINE Users’ Group Meeting are also available online.
The National Institutes of Health has created a new web site, NIH Clinical Research Trials and You, to help people learn more about clinical trials, why they matter, and how to participate. Clinical trials are essential for identifying and understanding ways to prevent, diagnose, and treat disease. Research has shown that among the greatest challenges to recruitment of volunteers is the lack of general knowledge about what trials involve, where they are carried out, and who may participate.
Visitors to the web site will find information about:
•The basics of clinical trial participation
•First-hand experiences from actual clinical trial volunteers
•Explanations from researchers
•Links on how to search for a trial or enroll in a research matching program
In addition, health care professionals can read about evidence-based strategies for talking with patients about trials, print audience-tested posters to help promote trials in clinics and offices, and find other educational materials. NIH supports clinical research trials across the country and throughout the world. NIH’s ongoing effort to raise awareness about clinical research and educate potential participants about clinical trial options is vital to developing public support and understanding for how clinical research drives medical discovery and improves health outcomes.
With its December update, PubMed Health grows to over 18,000 systematic reviews and health technology assessments in the last ten years. With the inclusion of the Database of Reviews of Effects (DARE) from the Centre for Reviews and Dissemination in England, PubMed Health is getting close to comprehensive coverage of reliable systematic reviews on clinical effectiveness.
Other new features and content additions in this release include:
- Evidence-based, regularly updated information on cancer for consumers and health professionals from the National Cancer Institute (NCI) Physician Data Query (PDQ) database.
- Two full-text books under “Understanding research results” from the “Understand clinical effectiveness” tab:
- Irwig L, et al. Smart Health Choices: Making Sense of Health Advice. London: Hammersmith Press; 2008. Available from: http://www.ncbi.nlm.nih.gov/books/NBK63638/
- Evans I, et al. Testing Treatments: Better Research for Better Healthcare. 2nd edition. London: Pinter & Martin; 2011. Available from: http://www.ncbi.nlm.nih.gov/books/NBK66204/
- Simplified and broadened display of medical encyclopedia search results.
For more information and screenshots of the December 2011 additions to PubMed Health, please visit NLM Technical Bulletin and PubMed Health.
The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, has stopped one arm of a three arm multi-center, clinical trial studying treatments for the lung-scarring disease idiopathic pulmonary fibrosis (IPF) for safety concerns. The trial found that people with IPF receiving a currently used triple-drug therapy consisting of prednisone, azathioprine, and N-acetylcysteine (NAC) had worse outcomes than those who received placebos or inactive substances.
The interim results from this study showed that compared to placebo, those assigned to triple therapy had greater mortality (11 percent versus 1 percent), more hospitalizations (29 percent versus 8 percent), and more serious adverse events (31 percent versus 9 percent) and also had no difference in lung function test changes. Participants randomly assigned to the triple- therapy arm also remained on their assigned treatment at a much lower rate (78 percent adherence versus 98 percent adherence).
The other two study arms, or intervention groups, of this IPF trial comparing NAC alone to placebo alone will continue. In stopping this part of the trial, the NHLBI accepted the recommendation of the Data and Safety Monitoring Board (DSMB) – an independent advisory group of experts in lung disease, biostatistics, medical ethics, and clinical trial design. The DSMB has been monitoring the study since it began.
Please visit the NLM website to read the entire clinical alert.
PubMed Health is a service provided by the National Center for Biotechnology Information (NCBI) at the U.S. National Library of Medicine (NLM). PubMed Health specializes in reviews of clinical effectiveness research, with easy-to-read summaries for consumers as well as full technical reports. Clinical effectiveness research finds answers to the question “What works?” in medical and health care. With the August and September 2011 releases, the PubMed Health homepage was redesigned and the number of items based on systematic reviews increased significantly.
PubMed Health is based on systematic reviews of clinical trials. These clinical effectiveness reviews can show what treatments and prevention methods have been proven to work, and what remains unknown. PubMed Health provides summaries and full texts of selected systematic reviews in one searchable resource. The reviews are generally published or updated from 2003. There is also information for consumers and clinicians based on those reviews. A search on PubMed Health runs simultaneously in PubMed’s “Clinical Queries” Systematic Reviews, using a filter to identify all the indexed scientific articles at the NLM that might be systematic reviews. This search includes articles prior to 2003.
Information partners selected by PubMed Health to contribute their clinical effectiveness information are:
- Agency for Health Care Research and Quality (US) (AHRQ)
- The Cochrane Collaboration (CC)
- German Institute for Quality and Efficiency in Health Care (IQWiG)
- National Health Service (NHS) National Institute for Health Research (NIHR) Health Technology Assessment Programme (NIHR HTA)
- National Institute for Health and Clinical Excellence guidelines program (NICE)
- Oregon Health and Science University’s Drug Effectiveness Review Project (DERP)
- Department of Veterans Affairs’ Evidence-based Synthesis Program from the Veterans Health Administration R&D (VA ESP)
Other key sections of PubMed Health include England’s Behind the Headlines service from the National Health Service (NHS Choices), medical encyclopedia from A.D.A.M. Education, and medication information from the American Society of Health-Systems Pharmacists.
To learn more about PubMed Health, including details about content and organization of the web site, please read the NLM Technical Bulletin or visit PubMed Health at http://www.pubmed.gov/health/.
NINDS has stopped the combination antiplatelet intervention in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial. This was a randomized, multicenter clinical trial conducted throughout North America, Latin America and Spain, to learn about preventing a second stroke in patients who had a subcortical stroke and to learn how to prevent cognitive problems after a stroke. Visit the NLM website for further information about the trial.
The National Institute of Neurological Disorders and Stroke (NINDS) has stopped enrollment in a clinical trial that is evaluating whether intracranial angioplasty combined with stenting adds benefit to aggressive medical therapy alone for preventing stroke in patients with symptomatic intracranial arterial stenosis. The study was the first prospective randomized multicenter trial to compare aggressive medical management alone versus aggressive medical management plus angioplasty combined with stenting in patients with symptomatic highgrade stenosis of a major intracranial artery. Recruitment began in November of 2008 and was halted on April 5, 2011 after 451 (59%) of the planned 764 patients had been enrolled at 50 participating sites in the US.
At the time of the most recent DSMB review, 14% of patients treated with angioplasty combined with stenting experienced a stroke or died within the first 30 days after enrollment compared with 5.8% of patients treated with medical therapy alone, a highly significant difference. The SAMMPRIS Executive Committee is in agreement with NINDS and the DSMB that enrollment in the study should be stopped and that the trial data currently available indicate that aggressive medical management alone is superior to angioplasty combined with stenting in patients with recent symptoms and high grade intracranial arterial stenosis. All are indebted to the patients who contributed to this important study.
Read the entire clinical alert at http://www.nlm.nih.gov/databases/alerts/intracranial_arterial_stenosis.html
NIH’s Office of Extramural Research has a new web site that provides information to help NIH applicants and grantees (recipients of extramural grants and cooperative agreements) understand their roles and responsibilities in relation to ClinicalTrials.gov and the Food and Drug Administration Amendments Act (FDAAA) of 2007. The information on this site may not apply to NIH contracts or NIH intramural research.
This site includes:
- an overview of FDAAA and its relationship to certain trials funded through NIH grants and cooperative agreements;
- an overview of registration and results reporting requirements;
- instructions for providing the NIH with certification of compliance with FDAAA; and
- FAQs for NIH grantees, definitions and acronyms, and other resources.
The site is available at: http://grants.nih.gov/ClinicalTrials_fdaaa/index.htm.